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bnP for pRediction of Outcome FollowIng Lung rEsection Surgery (PROFILES)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
Lung cancer is the second most common type of cancer in the UK and the leading cause of cancer related death. Surgery to remove the tumour and the surrounding lung (lung resection) often provides the best chance of cure. Frequently, patients are smokers with related lung or heart problems increasing the risks associated with surgery. Whilst surgery for lung cancer is considered the best chance of 'cure', patients may suffer long term breathlessness, lowering quality of life. This is important; public engagement work we have performed demonstrates repeatedly that second only to "being alive and cancer free" exercise capacity is the main priority of post-operative patients.
Prediction of breathlessness is difficult and not solely caused by lung removal but also from decreased performance of the heart. Although the surgery does not directly involve the heart, it is thought the damage is caused indirectly by the surgery and by removal of part of the lung. Current methods for predicting the risk of breathlessness after surgery are inaccurate. Some patients are refused surgery based on these methods yet may have had successful surgery. Furthermore, no specific treatment exists for patients considered to be at increased risk of breathlessness.
By identifying patients at risk of breathlessness, we believe an opportunity exists to intervene. A small study we completed (a 'pilot study') suggests measuring a hormone called 'BNP' (B type- natriuretic peptide, released by the heart) will improve prediction of post-operative breathlessness.
With informed consent, BNP blood levels will be measured before and after lung resection in 250 patients at 4 hospitals across the UK. We will target 100 patient recruitment at the Golden Jubilee and 50 from the other 3 centres involved. Validated questionnaires will be distributed following surgery measuring breathlessness and quality of life and returned via post at three months and at one year. Questionnaires were selected via patient and public involvement to represent what matters most to patients following surgery. This data will be integrated into current scoring systems to prove it increases identification of patients who will suffer from breathlessness and poor quality of life following surgery. Creation and testing of a risk prediction tool, or 'score', requires complex statistical techniques; we are therefore working alongside specialist biostatisticians.
We hypothesise post-operative cardiac dysfunction significantly contributes to postoperative dyspnoea and a window of opportunity exists peri-operatively where targeted interventions could improve outcome. In this study, by incorporating BNP measurement into clinical risk prediction of post-operative dyspnoea in patients undergoing lung resection surgery can we improve prediction of a poor functional outcome?
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Glasgow, Verenigd Koninkrijk, G81 4DY
- Werving
- Golden Jubilee National Hospital
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Contact:
- Brian Lafferty, MBChB
- Telefoonnummer: 0141 951 5000
- E-mail: brian.lafferty@nhs.net
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Contact:
- Ben Shelley, MBChB
- E-mail: ben.shelley@glasgow.ac.uk
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Provision of informed consent
- Age >16 years
- Planned elective lobectomy/pneumonectomy lung resection by VATS or thoracotomy.
Exclusion Criteria:
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Conditions that increase BNP artificially such as sepsis, cirrhosis, colon cancer and any intracranial pathologies (see definitions below)
- MRC score > 2 pre-operatively
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Shortness of Breath
Tijdsspanne: 3 months
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Modified MRC score.
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3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of life using quality of life questionnaire
Tijdsspanne: 3 months
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EQ-5D Qol questionnaire
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3 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 0.6 18/LO/1563
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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